Safety and immunogenicity of Heptavalent Conjugate Vaccine against Pneumococcal in healthy adults. Phase I.

Biomolecular Chemistry Center (CQB)0 个研究点目标入组 40 人开始时间: 2012年7月20日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Prevention

•1. Subjects aged between 18 and 35 (including the limit ages) 2. General, regional and specific physical examination without any alteration. 3. Vital signs within the following limits: - Sistolic Blood Pressure < 140 mmHg - Diastolic Blood Pressure < 90 mmHg - Heart rate80 ± 20 per minute - Respiratory rate16 ± 4 per minute - Temperature< 37 0C 4. Subject with hemoglobin rate above 12.5 g/L and other laboratory findings within the range of reference values. 5. Body Mass Index (BMI) between 18.5 and 29.9 (including the limits). 6. Subjects who express their consent to participate in the study written.

•1. Chronic diseases such as Asthma, Chronic Obstructive Pulmonary Disease (COPD), Ischemic Heart Disease, High Blood Pressure (hypertension), Diabetes mellitus (DM), thyroid disease, Epilepsy, neuropathies or diseases of the haemolymphopoietic system. 2. Immunosuppresive diseases, either congenital or acquired. 3. Fever or acute infection within ten (10) days prior to vaccination or upon the shot. 4. Severe allergic disease or immune system diseases. 5. Renal and / or hepatic failure. 6. Hypersensitivity to thimerosal or any of the other components of the formulation. 7. Mentally handicapped 8. Convulsive encephalopathies 9. Immunostimulatory or immunosuppressive therapy, blood products or other vaccinations in a period of 2 months 10. Subject with a history of previous vaccination against Streptococcus pneumoniae 11. Alcoholism.

发起方

Biomolecular Chemistry Center (CQB)